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Julius DeSilva
Published: Tuesday, May 5, 2020 - 12:03 ISO 9001 certifications have seen a decline during the past two years, per data from ISO. Some say the standard has gotten too complicated with the introduction of organizational context, risk-based thinking, and the removal of mandatory documented procedures. Even a few of QMII’s clients have considered letting their certification lapse because conformity to the new standard was perceived as too complex. Let’s begin by looking at the purpose of ISO 9001. The standard provides a framework for organizations looking to put in place a system that will enable them to consistently deliver products or services that meet their customers’ requirements and enhance their satisfaction. ISO 9001 certification is external validation that the system meets the requirements of ISO 9001. However, ISO 9001 allows organizations to use the standard and self-declare conformity without incurring the cost of certification. Many argue that there is no value in doing this. This is probably correct if you are implementing a system to meet a contractual or customer requirement. In these cases, certification is a requirement. Organizations that implement ISO 9001 for the benefits it will deliver in improved productivity, reduction in process waste, and management of risks have seen the bottom line improve with time.1 If implementing the standard enables consistent quality, why then the reluctance? Perhaps the trust in the ISO 9001 certification process has declined over time. Often have we heard from quality managers of the challenges faced when they raise nonconformities in internal audits. These are often viewed as finger-pointing exercises because the certification body has already audited and “cleared” (i.e., certified) the system. We have also heard from clients of certification bodies and auditors wanting to view documented evidence of organizational context, stakeholder needs, and risks. However, the standard does not require these to be documented and leaves it up to the organization to determine the risk of not doing so. Some auditors, however, struggle with auditing undocumented systems and auditing to the new standard.2 As a result, organizations start documenting their systems for the auditors and certification bodies, which results in a system tailored for auditors and forced on the organization. Auditors are meant to provide inputs to top management to help them make better decisions; instead, auditors and audits now have become the product. The standard’s intent to act as a preventive tool gets lost in this compliance process. The system must be designed for employees, not for auditors. During the past two decades there have been several mergers and acquisitions leading to larger multisite organizations and perhaps as a result a reduction in certifications. As these organizations have grown, and maybe in part owing to the declining trust in the certification system, they have decided to conduct their own supplier audits. As such, suppliers have chosen to let their certifications lapse because they are nevertheless being audited by the customer and that is the audit that really counts for them. Supplier audits are more focused on the customer contractual requirements. Organizations that perceive ISO 9001 as a documentation burden will then document only the parts of the system to meet contractual requirements rather than to meet the organization’s requirements based on ISO 9001. These organizations fail to see that ISO 9001 leaves the extent of system documentation up to the organization and often perceive the standard as requiring everything to be documented. Although quality does matter, and customers are still looking to receive a quality product, oftentimes incorrect interpretation of the standard leads many to forgo ISO 9001 certification. At times other certification requirements, like CE marking, may be more desired and certification to two standards burdensome. In that case, ISO 9001 certification gets the boot. Organizations looking to gain the benefits of a quality management system need not reinvent the wheel. ISO 9001 provides the framework that essentially reflects business 101. If you don’t need ISO 9001 certification, then you can self-declare and let the doubters come and assess your system for themselves. In the meantime, you will still gain from a well-implemented management system. Remember, you already have a system that has brought you thus far; align ISO 9001 to your system, and not your system to ISO 9001. References Quality Digest does not charge readers for its content. We believe that industry news is important for you to do your job, and Quality Digest supports businesses of all types. However, someone has to pay for this content. And that’s where advertising comes in. Most people consider ads a nuisance, but they do serve a useful function besides allowing media companies to stay afloat. They keep you aware of new products and services relevant to your industry. All ads in Quality Digest apply directly to products and services that most of our readers need. You won’t see automobile or health supplement ads. So please consider turning off your ad blocker for our site. Thanks, Julius is a Senior Vice President with Quality Management International Inc. A former merchant marine officer, he has assisted organizations of varied sizes across a wide spectrum of industries implement process based management systems conforming to ISO and other standards. He is well versed in the following standards: maritime safety/security, aerospace, environmental, supply chain security, and quality. He teaches, consults and audits in these disciplines, including process improvement and leadership related topics. Julius received his MBA from the Darden School of Business, University of Virginia. He is a PECB Certified ISO 9001 Lead Auditor and is a member of the Nautical Institute.The Decline in ISO 9001 Certification: Does Quality Matter Anymore?
Even if you don’t get certified, you will still gain from a well-implemented management system
To certify or not
Waning trust in the system
Supplier audits
Conclusion
1. Guasch, Luis J.; Racine, Jean-Louis; Sanchez, Isabel; and Diop, Makhtar. Quality Systems and Standards for a Competitive Edge. World Bank, 2007.
2. Fonseca, Luis; and Domingues, Pedro. “The Results Are In.” Quality Progress, October 2017.
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Julius DeSilva
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Comments
Make the standard the servant, and not the master.
" align ISO 9001 to your system, and not your system to ISO 9001" is essentially what I tell people; make ISO 9001 the servant and not the master. Organizations will get much more out of it if they view it from this perspective.
Does Quality Matter Anymore?
Hey Julius,
Good article. Interesting because in my opinion being in several industries and still fairly young millenial Quality Manager Quality still matters. The question is how is it evolving? With the ever changing market and turnover our Quality systems need to be alot more robust and flexible. ISO has this connontation of being a long and cumbursome process to ensure you check all the boxes. At the end of the day yes i agree that a system like this gives you the framework but the maintenance and time it takes is propbably not worth the reward? Do i have the answer to replace ISO? No. I just think we need to start thinking as you mentioned how can we adapt it to our system vs the old school thought of adapting ourselves to it. Thanks again.
The eventual demise of ISO 9001
Organizations have a management system, regardless of the fact it may or may not be related to TC 176 precepts set forth in ISO 9001. So why do organizations today need ISO 9001? The truth is … Most don’t.
The management systems of most current organizations are already focused upon customer satisfaction and have been for decades. ISO 9001 has shown not ability to weed out corruption within the system. With China being ISOs largest customer, there is now objective evidence that many certifications in that country are faux registrations, purchased through certification mills. What was your organizations latest non-conformance? Document Control? Or maybe Training Records? … Were either of these helpful at improving your organization?
Look no further than the serious quiestions raised related to the occurrence of disasters (both of products and finances) which befall ISO certified organizations…. Did no auditor see any of this brewing? As an auditor myself, I have raised many questions in the past which came back to bite organizations right square in their preverbal hinder parts, but did they ever listen to me initially when I brought the concern to their attention?.... Nope.
If there is ever to be a control of product acceptance (aka quality), it will occur at the behest of the consumer and their opinion about an organization’s products or services, nowhere is that more evidence than with the advent of social media and related consumer comments. Look at examples such as Amazon, products live and die based upon the customer response and score. I can’t state the number of times I have observed people reject a product because it simply had too many valid complaints.
And that is where the future will lie. The ability for consumers to rate products online, in direct reference to their purchases, and the ability of organizations to respond with corrective action to both satisfy current customers and appease future customers. Its certainly not going to be a bunch of auditors sitting in a small room who are eventually going to score organizations concerning their quality… it will be the product or service consumers…. and that is as it should be. I foresee an internet consumer quality rating becoming the norm, one in which organizations will need to work diligently to acquire and more diligently to retain their consumer perception and acceptance. ISO, I see becoming part some history book within a 5 year time span, placed right next to quality circles.